According to the Complaint, Zosano Pharma Corporation is a clinical stage pharmaceutical company. Its proprietary intracutaneous delivery system purports to offer rapid absorption of drug, consistent drug delivery, improved ease of use, and room-temperature stability. Its intracutaneous patch consists of an array of titanium microneedles that is coated with Zosano’s proprietary formulation of a previously approved drug that is attached to an adhesive patch. The patch purports to offer rapid and consistent delivery of the drug via the microneedles that penetrate the skin, resulting in dissolution and absorption of the drug.

The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the Complaint alleges Defendants failed to disclose to investors: (1) that the Company’s clinical results reflected differences in zolmitriptan exposures observed between subjects receiving different lots; (2) that pharmocokinetic studies submitted in connection with the Company’s NDA included patients exhibiting unexpected high plasma concentrations of zolmitriptan; (3) that, as a result of the foregoing differences among patient results, the FDA was reasonably likely to require further studies to support regulatory approval of Qtrypta; (4) that, as a result, regulatory approval of Qtrypta was reasonably likely to be delayed; and (5) as a result of the foregoing, Defendants’ public statements were materially false and misleading at all relevant times.